1. OIVD Workshop Premarket Notification (510(k)) April 22, 2003 Parklawn Building Rockville, MD Presented by Marjorie Shulman Premarket Notification Staff Office of Device Evaluation Center for Devices and Radiological Health (301) 594-1190 x 144

2. What is a 510(k)? Premarket Notification Section 510(k) of F,D, & C Act 21 CFR 807 Subpart E Marketing Clearance Application Allows FDA to Determine Substantial Equivalence (SE)

3. What a 510(k) Is Not A form Establishment Registration (FDA-2891) Device Listing (FDA-2892) Premarket Approval (PMA) Product Development Protocol (PDP)

4. A Device is Substantially Equivalent (SE) if: In Comparison to a legally marketed device, it: Has the same intended use, and Has the same technological characteristics as the predicate device, or:

5. SE (cont.) Has the same intended use, and Has different technological characteristics and the information in the 510(k): Does not raise new questions of safety and effectiveness, and Demonstrates it is as safe and effective as the predicate

6. May 28, 1976 PREAMENDMENT DEVICE: Exempted (with Conditions) from Marketing Clearance POSTAMENDMENT DEVICE: Requires Marketing Clearance

7. Establish Equivalence to: A legally marketed device that does not require a PMA, i.e., a: Preamendments device, or A device found by FDA to be Substantially Equivalent (SE), or A reclassified device

8. FDA finds the device Substantially Equivalent? NO: PMA Application or PDP Application or DeNovo Application YES: To Market

9. 510(k) Submission Required When: Introducing a device to the market for the first time Change in intended use for a marketed device Making significant modification to a marketed device

10. Modifications - Changes in Intended Use Modifications that significantly enhance (or decrease) Safety or Effectiveness, e.g. -change in design, materials, chemical composition, energy source, or manufacturing process Guidance: “Deciding When to Submit a 510(k) for Change to an Existing Device” (1/10/97)

11. Who Must Submit a 510(k) Manufacturers Specifications Developers Repackagers who change device or its labeling Relabelers who change the labeling, e.g., instructions for use

12. Who is Not Required to Submit a 510(k) Private Label Distributor who only adds company name and wording such as: “Distributed by ___________” or “Manufactured for _________”

13. Not Required to Submit (cont.) Repackager who does not alter labeling Distributor or Importer who furthers marketing of the device and does not alter labeling or change device

14. Devices Exempt from 510(k) Unfinished Device Class I and II devices exempt by statute or regulation Finished device not sold in U.S. Device covered under another 510(k), i.e, private labeled device Preamendment device Custom Device

15. 510(k) Content and Format 21 CFR 807.87 and 807.90 Device Advice Device Specific Guidance 510(k) Refuse to Accept Checklist

16. 510(k) Format Cover Letter or Cover Sheet User Fee Payment ID Number Table of Contents 510(k) Checklist Correct Pagination Required Information 1.5” left margin, unbound

17. Information Requested in 510(k) (21 CFR 807.87) Submitter’s name, address, phone/fax #, contact person, rep./consultant name, establishment registration number Device Classification Name, CFR number, device class, procode Common/usual name and trade/proprietary name and model numbers

18. Information Requested (cont.) (21 CFR 807.87) Identification of marketed device(s) to which equivalence is claimed Compliance with section 514 Special Controls Proposed labels, labeling, and advertising

19. Information Requested (cont.) (21 CFR 807.87) Photographs, engineering drawings Substantially equivalent statement and comparison with predicate Statement of similarities and/or differences with predicate device Data for changes for modified devices

20. Information Requested (cont.) (21 CFR 807.87) 510(k) MUST include either: 510(k) Statement510(k) Summary Applicant givesFDA provides 510(k) info to orthe summary to requestersrequesters via within 30 daysFOI process & Internet *Content and Format (21 CFR 807.92 & 807.93)

21. Information Requested (cont.) (21 CFR 807.87) Class III 510(k) must include: Certification and literature search has been conducted, and Summary of adverse S&E data with citation to the literature *Content and Format (21 CFR 807.94)

22. Information Requested (cont.) (21 CFR 807.87) Indications for Use Statement Truthful and Accurate Statement Proposed labeling Adherence to voluntary standard Financial Certification or Disclosure Statement or both

23. Information Requested (cont.) (21 CFR 807.87) Performance Data (bench, animal, clinical) Sterilization, Software and Hardware Information, if any Address information requested in specific guidance documents

24. Clinical Data in 510(k) 10-15% of all 510(k)s Important difference with the predicate device Must be collected under IDE (21 CFR Part 812)

25. FDA Requests Additional Information for: Incomplete submissions (Refuse to Accept) When testing data is required to demonstrate equivalence

26. Additional Data (cont.) Reviewer request by phone or letter Forward to Document Mail Center 30 days to submit May request extension of time

27. FDA Review Procedure Application Log-in Division Acceptance Assignment to Reviewer/Review Group ODE Review FDA Issues Decision letter SE Decision Made Public Within 30 days

28. 510(k) Paradigm Special 510(k) Abbreviated 510(k)

29. Special 510(k): Device Modification Manufacturer modifies own legally marketed device & determines that a 510(k) is required Modification does not affect intended use or fundamental scientific technology

30. Special 510(k): Device Modification Manufacturer assesses modification in accordance with 21 CFR 820.30 510(k) is submitted with “declaration of conformity” to design controls and summary of design control activities Description of modified device and comparison to cleared device Previous intended use and new intended use FDA processes in less than 30 days

31. Summary of Design Control Activities Risk analysis method(s) used to assess impact of the modification of the device Results of risk analysis Verification and/or validation activities required (including methods and acceptance criteria) Declaration of conformity with design controls

32. Declaration of Conformity to Design Controls Statement that all verification and/or validation activities were preformed and results demonstrate that the acceptance criteria were met Statement that manufacturing facility is in conformance with DC procedure requirements Statements must be signed by designated individual(s)

33. Abbreviated 510(k) Manufacturer intends to market new “reserved” Class I, Class II or Class III device Device is subject to special controls/FDA guidance or standard(s) Manufacturer uses special controls/FDA guidance or conforms to standard(s)

34. Abbreviated 510(k) Required elements of 21 CFR 807.87 510(k) submitted with summary information on special controls and/or “declaration of conformity” with standard(s)

35. Confidentiality of Information 21 CFR 807.95

36. Misbranding by Reference to 510(k) 21 CFR 807.97

37. Suggestions Submit two copies Clearly label what type of 510(k) Paginate accurately Include Table of Contents Include 510(k) Screening Checklist citing page numbers

38. 510(k) Statistics FY’s 00, 01 and 02 510(k)s Received: FY 00 - 4,204 FY 01 - 4,254 FY 02 - 4,320 510(k)s Logged Out: FY 00 - 4,397 FY 01 - 4,148 FY 02 - 4,376

39. 510(k) Statistics FY’s 00, 01 and 02 Average Review Times FY 00 - FDA Days 77Total Days 104 FY 01 - FDA Days 74Total Days 106 FY 02 - FDA Days 79Total Days 100 Cycles FY 00 - 1.42 FY 01 - 1.38 FY 02 - 1.39

40. Appeal Process Normally under 21 CFR 10.75 For any decision - hold letter - not equivalent - policy matter May request a meeting Will receive written response

41. Appeal Process (cont.) Guidance Available - Medical Device Appeals and Complaints - Resolving Scientific Disputes Concerning the Regulation of Medical Devices Status

42. 510(k) Rescission Regulation Currently Under Development Current Reasons -Significant Public Health Risk(s) -Fraud -Other Compelling Reasons

43. MDUFMA Medical Device User Fee and Modernization Act of 2002 www.fda.gov/cdrh/mdufma Contact DSMICA: (800)638-2041 or (301)443-6597 Send an email to: MDUFMA@cdrh.fda.gov

44. MDUFMA (cont) First year fee = $2,187 per 510(k) Reduced fee to protect small businesses. Small = sales and receipts less than $30 million Small business fee for 510(k) starts FY 04 Sunset October 1, 2007 No fee for Third Party 510(k)

45. 510(k) Guidance Websites The New 510(k) Paradigm - www.fda.gov/cdrh/ode/parad510.html Frequently Asked Questions and Answers on Paradigm - www.fda.gov/cdrh/ode/qanda510k Determination of Intended Use for 510(k) Devices -www.fda.gov/cdrh/ode/k98-1.html

46. 510(k) Guidance Websites General/Specific Intended Use - www.fda.gov/cdrh/modact/genspec.html Class I Exemption Regulation - www.fda.gov/OHRMS/Dockets/98fr/011400a.pdf Class II Exemption Regulation -www.fda.gov/cdrh/modact/frclass2.html

47. 510(k) Guidance Websites Convenience Kit Interim Regulatory Guidance - www.fda.gov/cdrh/ode/convkit.html Evaluation of Automatic Class III Designation - www.fda.gov/cdrh/modact/classiii.html Procedures for Class II Device Exemptions from 510(k) - www.fda.gov/cdrh/modact/exemii.html

48. 510(k) Guidance Websites Deciding when to Submit a 510(k) for a Change to an Existing Device -www.fda.gov/cdrh/ode/510kmod.html Preamendment Status Determination -www.fda.gov/cdrh/preamend.html Blue Book Memo: Fax & E-mail Comm. - www.fda.gov/cdrh/ode/A02-01.html

49. 510(k) Guidance Websites Device Advice - www.fda.gov/cdrh/devadvice Good Guidance Practices - www.fda.gov/cdrh/ggpmain.html Medical Device Appeals and Compliants - www.fda.gov/cdrh/modact/dispres1.pdf Resolving Scientific Disputes Concering the Regulation of Medical Devices -www.fda.gov/cdrh/resolvingdisputes/1121.html

50. 510(k) Guidance Websites Expedited Review - www.fda.gov/cdrh/modact/expedite.html Redacted Version of 510(k)s - www.fda.gov/OHRMS/DOCKETS/98fr/ 122199a.txt Reuse of Single Use Devices - www.fda.gov/cdrh/reuse/index.shtml

51. FDA Guidance Documents Facts-on-Demand: 1-800-899-0381 (Index is #919) 301-827-0111 Division of Small Manufacturers, International and Consumer Assistance (DSMICA) 1-800-638-2041 or 301-443- 6597 Internet: http://www.fda.gov/cdrh